Internal nasal dilator and medicine delivery method

ABSTRACT

A method of making an internal nasal apparatus ( 10 ) configured to retain and deliver a quantity of compound within the nose of a user over a minimum period.

RELATED APPLICATIONS

The present application is a continuation-in-part and claims prioritybenefit with regard to all common subject matter of an earlier-filedpending U.S. patent application of same title, Ser. No. 11/065,677,filed Feb. 24, 2005. The identified earlier-filed pending application ishereby incorporated by reference into the present application.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to mechanisms and methods fordilating nasal passages and delivering medications, drugs, or othercompounds. More particularly, the present invention concerns an improvedinternal nasal dilator for increasing nasal breathing efficiency and fordelivering a time-released compound within the nostrils of a user, and amethod of making the same.

2. Discussion of the Prior Art

It is well documented that collapsed or constricted nasal passagewaysresult in a multitude of bodily problems, including sleep apnea, sinusinfection, and other respiratory ailments. Another well-known problemassociated with reduced passageways is snoring. In this condition,audible sounds produced by the vibration of the soft palate and internalnasal structure can be a nuisance to persons within hearing distance andcan affect the quality of sleep of the snoring person.

To alleviate these ailments and conditions, a variety of nasal dilatormechanisms, including external and internal versions, have beendeveloped over time. Prior art external nasal dilators often take theform of an adhesive strip that is worn on an exterior portion of thenose and function to lift the walls of the nasal passages.Unfortunately, the frictional grab-strength required by these externaldilators often causes discomfort or damage to the skin and soft facialtissues of the user. Furthermore, external placement of these dilatorsexposes them to a variety of forces arising from rubbing againstobjects, such as pillows, that can prematurely dislodge the dilator.

Prior art internal nasal dilators function within the nostrils of theuser, and, as a result, are not subject to being prematurely dislodgedby external forces. These dilators are typically held in place by aclamping mechanism that pinches the septum generally along two contactpoints, or by stretching the nostrils enough to result in a compressiveforce on the dilator sufficient to hold it in place. Thenon-adjustability of these dilators, however, are problematic given thatthere are an infinite number of sizes and shapes of human nostrils. Thepinching mechanisms of these dilators are also problematic in that theycause discomfort to the user, including pain where prolonged usage isnecessary. The fact that some of these internal dilators must stretchthe nostrils to a greater extent than is necessary to simply dilate thenostril also causes further discomfort and noticeability.

The prior art also includes nasal mechanisms combined with gaseousdelivery systems for providing a measured flow of medicine to the user.These combinations, however, typically require that an external sourcebe securely connected to the mechanism during usage, which makes themproblematically cumbersome. Connection to an external source alsoreduces comfort by limiting the user to certain positions in order toensure proper operation, which may further inhibit the user fromsleeping. Furthermore, these combinations include notoriously complexmechanical, electrical, or pneumatic components that make theirmanufacture time-consuming and expensive.

Due to these and other problems and limitations in the prior art, animproved nasal dilator and delivery mechanism is needed.

SUMMARY OF THE INVENTION

The present invention overcomes the problems and limitations in theprior art by providing an improved internal nasal dilator for increasingnasal breathing efficiency and for delivering a time-released compoundwithin the nostrils of a user, and a method of making the same.

A first aspect of the invention concerns an internal nasal dilatoradapted for use within a nose having first and second nostrils separatedby a septum, with each of the nostrils defining in part an internalnasal passageway and an interior outer wall surface generally oppositethe septum. The dilator comprises a generally U-shaped clip configuredto contact and apply a holding force to the septum when the dilator isdonned. The clip is further configured to contact the septum along firstand second planar engaging surfaces. The dilator also includes first andsecond nostril expanders, wherein each of the expanders further includea nostril engaging element configured to overlay and conform to aportion of the interior outer wall surface of said first or secondnostril, and an arm interconnecting the nostril engaging element andclip. The element, arm and clip are cooperatively configured to exert aforce upon said portion of the interior outer wall surface.

A second aspect of the invention concerns an internal nasal apparatusadapted for use within a nose having first and second nostrils separatedby a septum, each of the nostrils defining in part an internal nasalpassageway, an outlet, and an interior outer wall surface generallyopposite the septum. The apparatus comprises a holding elementconfigured to contact and apply a holding force to the nose so as tosecure the apparatus at least partially within both nostrils when theapparatus is donned, and first and second delivery elements. Each of thedelivery elements is configured to retain a quantity of a medicine,drug, or other compound within the nasal passageway of one of said firstor second nostrils and to discharge the quantity within the nasalpassageway at a minimum distance from the outlet of said one of saidfirst or second nostrils over a minimum period of time.

A third aspect of the present invention concerns a method of increasingthe efficiency of nasal breathing and delivering a compound within anose having a septum and first and second nostrils, wherein each nostrildefines an inner outer wall surface, and a nasal passageway. The methodcomprises the steps of engaging and applying outward forces to the innerouter wall surfaces, and engaging and applying compressive forces to theseptum, so as to retain the nostrils in an expanded open position; andretaining a quantity of a medicine, drug, or other compound within thenostrils and gradually discharging the quantity at a minimum distancewithin the nasal passageway and over a minimum period of time.

The present invention also concerns an improved method of making theinternal nasal apparatus and compound delivery system. Moreparticularly, the present invention concerns a method of making aninternal nasal apparatus adapted for retaining and delivering a quantityof compound within the nose of a user. The method comprises the steps ofproviding an internal nasal apparatus having first and second deliveryelements configured to be inserted within the nose of the user,providing a quantity of compound containing a desired agent, providingfirst and second mold cavities, or negative molds, configured to receivesaid first and second delivery elements and said quantity of compound,inserting at least a portion of said first and second delivery elementswithin the molds, inserting said quantity of compound within the moldsand adjacent said portion, adhering the compound to said portion, andremoving said molds to expose said quantity of compound.

Other aspects and advantages of the present invention will be apparentfrom the following detailed description of the preferred embodiment andthe accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Several embodiments of the invention are described in detail below withreference to the attached drawing figures, wherein:

FIG. 1 is a perspective view of an internal nasal dilator constructed inaccordance with a first preferred embodiment of the present invention,particularly illustrating the dilator being donned by a human user;

FIG. 1 a is a schematic side-elevational view of the inner-structure ofthe human nose;

FIG. 1 b is an interior view of the human nose;

FIG. 2 is a plan view of the dilator shown in FIG. 1 in its normalcondition;

FIG. 3 is a cross-sectional view of the dilator taken along the line A-Ashown in FIG. 2, particularly illustrating the connection between thedisk and arm;

FIG. 4 is a plan view of an internal nasal dilator shown in FIGS. 1through 3, having two compound delivery elements;

FIG. 5 is an enlarged fragmentary plan view of the dilator, particularlyillustrating a compound delivery element;

FIG. 5 a is an enlarged fragmentary cross-sectional view of a removablyfixed connection between a compound delivery element and an arm inaccordance with a preferred embodiment of the present invention;

FIG. 5 b is an enlarged fragmentary plan view of the compound deliveryelements, particularly showing the adjustable overlay;

FIG. 6 is a perspective view of an internal nasal dilator constructed inaccordance with a second preferred embodiment of the present invention;

FIG. 7 is a side-elevational view of the dilator shown in FIG. 6;

FIG. 8 is a front-elevational view of the dilator shown in FIGS. 6 and7, particularly showing two compound delivery elements; and

FIG. 9 is a plan view of the dilator shown in FIGS. 6 through 8 in itsnormal condition, particularly showing the compound delivery elementsand septum engaging pads;

FIG. 9 a is fragmentary side elevational view of a compound deliveryelement prong defining a plurality of openings;

FIG. 9 b is a fragmentary side elevational view of a compound deliveryelement prong defining a continuous slot;

FIG. 10 is an isometric view of the internal nasal dilator constructedin accordance with a second preferred embodiment of the presentinvention; and

FIG. 11 is a plan view of the dilator shown in FIG. 10.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the figures, a nasal dilator, delivery mechanism, andmethod of making the same are herein described, shown, and otherwisedisclosed in accordance with the preferred embodiments of the presentinvention. More specifically, the present invention concerns an improvedinternal nasal dilator for increasing nasal breathing efficiency and fordelivering a time-released compound within the nostrils of a user, and amethod of making the same.

As best shown in FIG. 1, a first preferred embodiment of the presentinvention concerns an improved internal nasal dilator 10 adapted for usepredominately within a nose. Although further described herein withrespect to a human user, the present invention may be modified in sizeand shape to properly function within the noses of a variety of animals.For example, the structure of the dilator 10 could be elongated andbroadened for equine or canine usage without departing from the presentinvention. It is also within the present invention to modify theconfiguration of the dilator, so long as compound storage and deliveryoccurs at the prescribed minimum distances within the nose.

Turning first to FIGS. 1, 1 a, and 1 b, the human olfaction organ isdivided into an external portion, i.e. the visible projecting portion12, to which the term “nose” is restricted herein, and an internalportion, consisting of two principal cavities, or nasal fossae 14,separated from each other by a vertical septum 16. Each of the nasalcavities 14 fluidly communicates with ambient air conditions through aconstricted orifice, or ostium internum 18, located at the union of thetwo portions. The nose 12 further presents first and second nostrils20,22 also separated by the septum 16. Each of the nostrils 20,22 definein part an internal nasal passageway 24, a nasal outlet 26, and aresistively elastic outer wall 28. The internal nasal passageway 24 asused herein, is limited to the vestibules formed by the nose 12, anddoes not include the nasal cavities 14 and other inner workings of theorgan. The passageway distance is defined as the linear distance alongthe longitudinal axis of the vestibules as measured from the outlet 26to the orifice 18. The outer wall 28 presents an interior outer wallsurface 30 generally opposite the septum 16. Finally, a mucosal lining31 further described herein overlays a significant portion of the nasalpassageways 24 and cavities 14.

As illustrated in FIGS. 2 through 5, the improved internal nasal dilator10 includes a septum constricting clip 32, and left and right-nasalexpanders 34,36 (i.e., dilating elements). The septum constricting clip32 is configured to retain and apply a holding force to a portion of theseptum 16. The preferred clip 32 presents a symmetric generally U-shapedbody having constant depth and thickness and defining interior andexterior clip surfaces 44,46. The clip 32 is formed by first and secondlinear portions 38,40 and a bent portion 42 interconnecting the linearportions 38,40. The bent portion 42 is configured so as to place thelinear portions 38,40 generally adjacent to the septum 16 by orientingthe linear portions 38,40 generally towards the septum 16. Thus, thelinear portions 38,40 are configured to converge as they approach theirdistal ends spaced from the bent portion 42. More preferably, tominimize internal obstruction, at least a section of the linear portions38,40 present tapered depths, as shown in FIG. 3. In this arrangement,the depth of the clip 32 gradually decreases as the linear portions38,40 approach their distal ends.

Improved septum engaging pads 48,50 are attached to the clip 32 adjacentthe distal ends and along the interior clip surface 44. Each of the pads48,50 are configured to engage the septum 16 along planar innermost clipsurfaces 52,54, so that the septum 16 is not pinched by point or minimalarea contact during usage. Each of the pads 48,50 presents a trapezoidalshape, wherein the innermost clip surfaces 52,54 are oriented generallyparallel to the septum 16 in the normal position (see FIG. 2). Morepreferably, each of the surfaces 52,54 presents a surface area not lessthan 0.2 square centimeters, and most preferably, not less than 0.5square centimeters. Finally, so as not to damage the mucosal lining 31during placement and removal, the preferred pads 48,50 present chamferedor filleted edges. It is believed that this improved designsignificantly increases comfort to the user, while stimulating thetrigeminal nerve and dilating the nasal passage.

Each of the nasal passage expanders 34,36 are virtually identicallyconfigured and, therefore, only nasal passage expander 34 will bedescribed in detail, with the understanding that nasal passage expander36 is similarly constructed. The expander 34 is configured to retain theouter wall 28 of the nostril 20 in an open or dilated position as shownin FIG. 1. In a first preferred embodiment of the present invention, theexpander 34 generally includes an arm 56 spaced from the nostril and anostril engaging disk 58 (see FIGS. 2 through 4). By engaging only theinterior outer wall surface 30 with the disk 58, the improved expander34 is configured to minimally engage the nostril 20, thereby reducingnoticeability.

More preferably, the arm 56 presents a thin planar body having a firstpair of opposite major surfaces 60, and a second pair of parallelsurfaces (not shown) generally perpendicular to the first. To reduceobstruction, the preferred arm 56 is oriented such that the majorsurfaces are parallel with the direction of airflow during respiration.At a first end 62, the arm 56 is fixedly attached to the clip 32 on theouter surface 46 near the distal end of linear portion 40. At theopposite second end 64, the arm 56 is flexibly fixed to the interiorsurface 66 of the disk 58. The preferred second end 64 presents an ovalor circular shape as shown in FIG. 3, which further enables disk 58flexure. However, other flexible connection configurations may beutilized, including ball-and-socket, without departing from the scope ofthe present invention. Also shown in FIGS. 2 and 3, the preferred firstand second ends 62,64 are enlarged in comparison to the remainder of thearm 56 for increased durability. To facilitate bending, the arm 56 ispreferably bowed in an arcuate shape as shown in FIG. 2.

The preferred disk 58 is configured to be comfortably inserted withinthe nasal passageway 24 and to evenly apply a force therein. Thepreferred disk 58 presents a thin slightly concave panel. As shown inthe illustrated embodiment, the panel is preferably oval in shape. Acircumscribing margin 68 extends continuously around the panel and isinverted towards the center of the panel, so as to present a roundedradially outermost disk portion similar to a frisbee. The disk 58presents a surface area sufficiently sized to engage only a portion ofthe outer wall 28 of the nostril 20.

As best shown in FIG. 4, where delivery of medicine, drugs, or othercompounds is desired the dilator 10 also includes left and rightcompound delivery elements 70,72 that are attached to respectiveexpanders 34,36. The compound delivery elements 70,72 are detached, i.e.not connected to an external source, and, more particularly, areconfigured to store and deliver a quantity of a compound 74 to themucosal lining 31. As used herein, the term “compound” includeselements, emulsions, suspensions, mixtures and other forms orcombinations of substance suitable for use with the present invention.Furthermore, it will be appreciated that the compound may be medicinalor non-medicinal in nature, and may, in that regard, include therapeuticor aromatic substances.

More preferably, the clip 32 and delivery elements 70,72 arecooperatively configured to discharge the compound 74 at a distance notless than twenty-five percent (25%) of the overall nasal passagewaylength, which is where the mucosal lining 31 fully transitions from theouter epidermal. It is also appreciated by those skilled in the relevantart that numerous tiny blood vessels, or capillaries, lie just under themucosal lining 31 of the nose, near the surface of the nasalpassageways, and that delivery of the compound 74 to the lining 31increases the efficiency of absorption into the blood stream. Mostpreferably, the clip 32 and delivery elements 70,72 are cooperativelyconfigured to gradually deliver the compound 74 at a distance not lessthan fifty percent (50%) of total passageway length within the nose, sothat compound 74 can also be absorbed by the lining 31 duringexhalation.

Each of the delivery elements 70,72 preferably presents a shallowcarrying receptacle 76 that defines at least one discharge opening 78.More preferably, the receptacle 76 presents a rectangular shape havingfilleted leading edges, so as not to damage the lining 31 duringplacement, and a plurality of discharge openings 78. The receptacle 76preferably includes a flared base section 80 for greater strength ofconnection to the arm 56. The openings 78 are located near and the floor82 of the receptacle 76 is preferably sloped towards the distal end ofthe receptacle 76, (see FIG. 5 a) so as to promote the discharge of thecompound during use.

The compound 74 and delivery elements 70,72 are configured to dischargethe compound 74 over a period of time. More preferably, the compound 74is discharged over a period of at least one hour, and, most preferably,over a period of four to twelve hours. In this regard, the preferredreceptacle 76 is ideally designed for carrying a time-released pastehaving sufficient viscosity to effect gradual discharge through theopenings 78. The paste may alternatively provide for the suspension anddelivery of airborne molecules into the passageway 24. It will beappreciated by those in the art that gradually discharging the compoundincreases the efficiency of absorption into the blood stream, and,therefore, the effectiveness of the active ingredients. Finally, to varythe discharge rate of the compound 74 a portion of the plurality ofopenings 78 can be safely overlaid with an adhesive-backed cover 84. Itis also well within the ambit of the present invention, however, toutilize other structures for storing and delivering a compound at theproscribed locations in conjunction with the nasal dilator 10. Forexample, a tubular capsule having a pervious wall or an absorbent foamcould be utilized.

The compound delivery elements 70,72 are preferably formed integrallywith the other dilator components. More preferably, however, thedelivery elements 70,72 are removably coupled to the dilator 10, andsafe-guards are incorporated to prevent unwanted dislodgment during use.As shown in FIG. 5 a, a plurality of button probes 86 are fixedlyattached to each delivery element, and a plurality of depressions 88 inthe corresponding arm are concentrically alignable, so as to enable thedelivery elements 70,72 and arms 56 to snap into the interfittedposition shown in FIG. 5 a. It is certainly within the ambit of theinvention, however, to provide other means for securing deliveryelements to the remainder of the dilator 10. For example, a small cotterpin, screw, or other type of conventional fastener that does notinterfere with the function of the nose could be utilized.

The dilator 10 is formed of any suitable non-toxic, hypoallergenic, andbendably rigid natural or synthetic material. More preferably, thedilator 10 is manufactured using a synthetic polymer composition. Theselected material and the configuration of the disk 58, however, ispreferably such that the preferred disk 58 is inelastically bendable andtherefore permanently conformable to the shape of the nostril 20. Thedilator 10 is preferably constructed through conventional means, such asinjection molding, and in a manner that results in seamless contact withthe user. At least a portion of the dilator 10, including the septumengaging pads 50,52 and nostril engaging disks 58, can be further moldedor double-dipped with a relatively soft material to present a morecomfortable outer interface. More particularly, the coating material maycomprise of a compressible soft foam, such as a urethane foamapproximately 0.025 centimeters thick. A suitable coating may also beutilized to provide other desirable characteristics, such asfluorescence for night-time viability.

The physical state of the compound 74 may be selected from among variousliquids, pastes, hard and soft gelatin capsules, solid pellets, andcombinations thereof. The compound 74 itself may comprise of any one orcombination of conventional nasal delivery agents, including ionic zinc,pain relief agents, antihistamines/decongestants, scenting agents,herbal supplements, insulin, growth hormones, asthma drug medication,germicides, microbicidal agents, and other beneficial agents. Thecompound may also include, for example, volatile oils such aseucalyptus; or the compound may be electrically charged for attractingand retaining pollen particles or other particulates and therebyextracting such particulates from the airflow; or the compound maycomprise magnetic materials for providing the health benefits that someattribute to exposure to magnetic fields. Thus, it should be understoodthat the compound may function to add/release to or remove/extract fromthe air flow through the nostrils.

In operation, after selecting a dilator 10 of a suitable size for theuser, the dilator 10 is installed by gently bending the expanders 34,36inward and slightly opening the U-shaped clip to increase the distancebetween pads 50,52. The expanders 34,36, linear portions 38,40 of theclip 32, and pads 50,52 are then inserted through the outlets 26 of thenostrils 20,22 and released. The dilator 10 is slid further into thenostrils and adjusted as necessary to reach the desired final location.More preferably, the dilator 10 is maneuvered into place such that thevertex of the bent portion 42 is adjacent the exposed portion of theseptum 16 (see FIG. 1). Once in place, the dilator 10 exerts holding anddilating forces upon the nose as it attempts to revert to its normaluncompressed condition shown in FIGS. 2 and 4. More particularly, theexpanders 34,36 apply outward biasing forces to the outer walls 28 tomaintain the nostrils 20,22 in the open position shown in FIG. 1, andthe pads 50,52 compress the septum 16 to help breathing and reducesnoring.

Where compound delivery is desired, the compound 74 is placed within orotherwise retained by attached delivery elements 70,72, prior toinstallation of the dilator 10. The compound 74 gradually dischargesfrom the elements 70,72 over a period of at least one hour, and, mostpreferably, over a period of four to twelve hours. Once the compound 74is depleted and dilation is no longer desired, the dilator 10 can beremoved and stored in a sanitized environment or simply disposed of. Ifstored, the dilator 10 can be reused by replacing the dissipatedcompound with a second quantity and re-installing the dilator 10, thoughthis ability will depend on the manner in which the compound is appliedto the dilator 10.

In a second preferred embodiment of the present invention, dilator 100is shown with a different configuration, particularly with regard to theexpanders 102,104 (see FIGS. 6 through 9). Dilator 100 may be similar todilator 10 in all aspects including material composition, manufactureand modes of operation, except for the following modifications, and, assuch, only those aspects of dilator 100 differing from dilator 10 willbe further described in detail herein.

As shown in FIG. 6, each of the preferably integrally formed expanders102,104 presents an arm portion 106 spaced from the nostrils 20,22, anda nostril engaging portion 108 adjacent to the distal end of the armportion 106. Like the expanders 34,36 of the first embodiment, theexpanders 102,104 of the second embodiment preferably present thinplanar bodies having first pairs of opposite major surfaces, and secondpairs of parallel surfaces (not shown) perpendicular to the first pairs.The major surfaces of the nostril engaging portions 108 preferablypresent greater lateral widths than do the major surfaces of the armportions 106 in order to more broadly apply the dilating force to thenostril. The arm portions 106 are preferably oriented such that themajor surfaces are parallel with the direction of air-flow duringrespiration.

As best shown in FIG. 6, the arm portion 106 is fixedly attached to aU-shaped clip 110 similar to the clip 32 of the first embodiment.However, unlike the dilator 10 of the first embodiment, the preferredexpanders 102,104 are fixedly attached to the top surface of the linearportions of the clip 110 and pads, and generally project diagonallyoutward toward two and ten o'clock positions in the normal condition.More preferably, the expanders 102,104 generally project from the topsurface of the clip 110 at an approximately forty-five degree verticalangle from horizontal. It is appreciated that where the flexible outerwall 28 defines a quarter circle between the face and septum 16 of theuser, maximum dilation is achieved by orienting the dilating forcevector in this direction.

The arm portions 106 preferably present upwardly bowed sections so as topromote bending and the application of a biasing force in a bent orflexed condition. As best shown in FIG. 8, the bowed sections morepreferably extend along the entire length of the expanders 102,104, sothat the expanders 102,104 present half circular or elliptical arcuateelevations. Also shown in FIGS. 6 and 8, the fixed ends of the expanders102,104 are thicker in comparison to the remainder of the arm portions106 for increased durability. The fixed end of each expander 102,104overlays and stems from the full top surface width of a pad and asection of a linear portion of the clip 110 adjacent its distal end.Finally, the dilator 100 preferably presents filleted edges and roundedcorners so as to prevent scraping and other damage to the mucosal lining31 (see FIGS. 6 and 9) during insertion and removal.

In the illustrated embodiment shown in FIGS. 6 through 9, the expanders102,104 are also upwardly bowed to facilitate proper functioning of thecompound delivery elements 112,114. As best shown in FIG. 9, thepreferred delivery elements 112,114 are affixed to the lower surfaces116,118 of the expanders 102,104, respectively. The preferred elements112,114 present cylindrical prongs 120,122 that project toward the faceof the user during use and generally perpendicular to the direction ofair-flow during respiration. It will be appreciated that thisconfiguration provides maximum interaction between the elements 112,114and air-flow. The prongs 120,122 are each configured so as not tocontact the mucosal lining 31 during use, and, more preferably, presentsa length of approximately less than one centimeter.

As shown in FIG. 9, prongs 120,122 are configured to receive and retaina quantity of a medicinal, therapeutic, aromatic, drug, or othercompound 124. Each of the prongs 120,122 preferably presents a pluralityof openings 126, or, alternatively, a continues open slot 128, (seeFIGS. 9 a,b) that aid in retaining the compound 124 on the prongs120,122. More specifically, the compound 124 is preferably applied toand received on the prongs 120,122 in such a manner that the compoundsubstantially covers the prongs 120,122 and passes completely throughthe prongs 120,122 at the locations of the openings 126 or slots 128.That portion of the compound 124 that passes through openings 126 orslots 128 acts as a structural retention mechanism to aid in retainingthe compound on the prongs 120,122.

While the material composition and manufacture of the dilator 100 of thesecond embodiment is similar to the dilator 10 of the first, theformation of the compound 124 onto the prongs 120,122 can beaccomplished by any conventional means including injection molding, hotmolding, manual dipping or the like. More preferably, the method offormation comprises the steps of providing the compound 124 in liquid orpaste form, providing two cavity molds, or negative molds, configured toform and release a product of desired dimension, inserting prongs120,122 within the molds, placing the compound within the molds andadjacent the prongs 120,122, and allowing the compound to solidify andadhere to the prongs 120,122 over a period of time.

Most preferably, the prongs are inserted completely within the molds,such that the molds abut the lower surfaces 116,118 of the expanders102,104, and the compound solidifies at room temperature, i.e.,approximately seventy-three degrees Fahrenheit, and approximatelysixty-five percent humidity within a period of four hours. Wheredesired, a catalyst may be added to the compound to accelerate the rateof curing to approximately thirty minutes or less, a releasing agent maybe added to the mold to facilitate removal of the cast, and a primer maybe added to the prong surface to facilitate adhesion. Finally,introduction of the compound and prongs into the molds is mostpreferably at least partially performed by conventional mechanicalmeans, such as a suitable injection molding machine. It will beappreciated by those ordinarily skilled in the art that other desirableadditives can be added to the compound; that any suitable conventionalcurative, catalyst, releasing agent, or primer effective for theintended purposes described may be utilized; and that the utilization ofmechanical means reduces manufacturing errors and increasesproductivity.

Where hot molding is utilized in formation, the process may include thesteps of providing the compound 124 in a solid form, such as pellets orcapsules, heating the molds to a temperature in excess of the meltingpoint of the solid compound 124, allowing the compound 124 to liquifyprior to inserting the prongs 120,122, and providing an additionalcool-down period to reduce the temperature of the compound 124. Morepreferably, a cool-down period of not less than approximately one-houris provided, while the molds and compound 124 are exposed to a suitablecooling source (not shown) configured to accelerate the rate oftemperature loss. It should be noted that in order to enable its properfunction, the compound 124 must have a melting point measurably greaterthan room temperature but less than the temperature typically presentwithin the nasal passageway 24, and more preferably approximatelybetween the range of 80° and 90° F.

In operation, the prongs 120,122 and the compound 124 are cooperativelyconfigured to deliver the beneficial agent to the user at a gradual rateand over a desired period of time by melting the compound so that theagent directly contacts the lining 31, by sublimation wherein thecompound 124 releases airborne particles into the nasal cavity 14, or acombination of the two.

Referring to FIGS. 10 and 11, a second preferred embodiment of the nasaldilator 600 is shown which may be substantially similar or identical tothe above-described first preferred embodiment but for the followingdifferences. Rather than supporting the compound on a projectingstructure, the compound is present in the form of an overlay 700, suchas a film, overmolded in the manner described above or otherwise appliedto the inner surfaces of the left and right nasal expanders 634,636. Thethickness of the overlay 700 may vary depending on such factors as thenature and characteristics of the particular compound. It iscontemplated, however, that, at least for some compounds, the overlay700 may be approximately 0.001 inches to 0.100 inches in thickness. Theoverlay 700 may comprise a suitable base, or carrier, such as glycerin,glycerol, or sodium hydroxide, which evaporates into the airflow withinthe nostrils; the compound may be suspended in the base so as to bereleased as the base evaporates. Use of a base provides one way ofcontrolling the rate at which the compound is released, either bychanging the formula of the base to control the evaporation rate or bychanging the concentration of the compound suspended in the base.Alternatively, the overlay 700 may include no base, in which case theoverlay 700 will be substantially or entirely the compound itself.

For example, an inhalable version of an antibiotic tobramycin solution(Tobi®) has been approved for use in suppressing pseudomonas aeruginosain the airways of patients with cystic fibrosis. Currently, the drug isaerosolized, or converted into a fine mist using a nebulizer device sothat it can be inhaled into the lungs. A nebulizer is a relativelycomplex and expensive device, and includes a mouthpiece or mask and anelectrically-powered air compressor. The present invention provides aless expensive, less complex, and more consistent and longer deliverymechanism for drugs such as Tobi® and other inhalables, includingbronchodilators (airway-opening) medications.

Additionally, it will be appreciated that moisture may be suspended inthe base or carrier, such that the evaporating base releases themoisture and, in effect, humidifies the air flow into the lungs.

The preferred forms of the present invention and modes of operationdescribed above are to be considered illustrative only, and should notbe utilized in a limiting sense in interpreting the scope of the presentinvention. Obvious modifications to the exemplary embodiments, as setforth above, could be readily made by those skilled in the relevant artswithout departing from the spirit of the present invention or thecontemplated scope of protection.

The inventor hereby states his intent to rely on the Doctrine ofEquivalents to determine and assess the reasonably fair scope of thepresent invention as pertains to any apparatus not materially departingfrom but outside the literal scope of the invention as set forth in thefollowing claims.

1. A method of making an internal nasal apparatus for retaining anddelivering a time-release compound within a nose of a user, the methodcomprising the steps of: (a) obtaining the internal nasal apparatushaving first and second delivery elements configured to be inserted intothe nose; and (b) applying the time-release compound to the first andsecond delivery elements such that when the first and second deliveryelements are inserted into the nose the compound is located with thenose and discharges over time within the nose.
 2. The method as claimedin claim 1, wherein the internal nasal apparatus is adapted to dilatethe nose to facilitate insertion and positioning of the first and seconddelivery elements within the nose.
 3. The method as claimed in claim 1,wherein the compound releases into an airflow within the nose.
 4. Themethod as claimed in claim 1, wherein the compound functions to extracta material from an airflow within the nose.
 5. The method as claimed inclaim 1, wherein the compound is a medicinal agent.
 6. A method ofmaking an internal nasal apparatus for retaining and delivering acompound within a nose of a user, the method comprising the steps of:(a) obtaining the internal nasal apparatus having first and seconddelivery elements configured to be inserted within the nose of the user;(b) providing first and second mold cavities configured to receive atleast a portion of the first and second delivery elements and thecompound; (c) positioning the at least a portion of each deliveryelement within a respective one of the mold cavities; (d) introducingthe compound into the mold cavities; (e) allowing the compound to adhereto the at least a portion of the delivery elements; and (f) removing theat least a portion of each delivery element from the respective one ofthe mold cavities once the compound has adhered.
 7. The method asclaimed in claim 6, wherein steps (a) through (f) are performedsequentially.
 8. The method as claimed in claim 6, wherein the compoundreleases into an airflow within the nose.
 9. The method as claimed inclaim 6, wherein the compound functions to extract a material from anairflow within the nose.
 10. The method as claimed in claim 6, whereinthe compound is a medicinal agent.
 11. The method as claimed in claim 6,further including the step of applying a primer on said portion, so asto increase a connection strength between the compound and portion. 12.The method as claimed in claim 6, further including the step of applyinga releasing agent on the molds, so as to decrease a connection strengthbetween the compound and molds.
 13. A method of making an internal nasalapparatus for retaining and delivering a solid compound within a nose ofa user, the method comprising the steps of: (a) obtaining the internalnasal apparatus having a delivery element configured to be insertedwithin the nose of the user; (b) providing a mold cavity configured toreceive at least a portion of the delivery element and the compound; (c)positioning the at least a portion of the delivery element within themold cavity; (d) heating the compound past its melting point; (e)introducing the heated compound into the mold cavity; (f) allowing thecompound to re-solidify and adhere to the at least a portion of thedelivery element; and (g) removing the at least a portion of thedelivery element from the mold cavity once the compound hasre-solidified and adhered.
 14. The method as claimed in claim 13,wherein steps (a) through (g) are performed sequentially.
 15. The methodas claimed in claim 13, further including the step of exposing thecompound to a cooling source in order to accelerate resolidification ofthe compound.
 16. The method as claimed in claim 13, said apparatusfurther having a holding element configured to apply a holding force tothe nose of the user, so as to secure the apparatus in a fixed position,wherein said delivery element is located within the nose of the user.17. The method as claimed in claim 13, wherein the compound releasesinto an airflow within the nose.
 18. The method as claimed in claim 13,wherein the compound functions to extract a material from an airflowwithin the nose.
 19. The method as claimed in claim 13, furtherincluding the steps of applying a primer on said portion, so as toincrease a connection strength between the compound and portion.
 20. Themethod as claimed in claim 13, further including the steps of applying areleasing agent on the mold, so as to decrease a connection strengthbetween the compound and mold.